JP2007501055A - Surgical kit and method for providing a sterilized instrument for use in spinal surgery - Google Patents

Abstract

A spinal implant (20) adapted to engage a portion of the spinal column, a series of instruments (12) adapted to be used in conjunction with spinal surgery, the spinal implant (20) and Surgical kit (10) and method for providing a sterilized instrument for use in spinal surgery comprising a package (14) adapted to contain the series of instruments (12) in a sterile condition.
[Selection] Figure 1

Description

  The present invention relates generally to surgical kits and methods for providing sterilized instruments for use in spinal surgery.

  There are various types and sizes of implants, devices, and instruments available for the treatment of various diseases, lesions, injuries, or malformations that affect the spine. To date, the components required for spinal surgical procedures have been provided separately to surgical facilities such as hospitals, trauma / outpatient centers, medical / research laboratories, surgical training facilities, and the like. A relatively high inventory to accommodate the various requirements associated with spinal surgical procedures (eg, anatomical requirements governing the choice of specific size and configuration of implants, devices, and / or surgical instruments) Levels have been secured and maintained.

  As will be appreciated, high inventory levels are expensive to secure and maintain, can be lost or damaged, and can also be stolen. Furthermore, even the most basic set of surgical instruments can be quite expensive. In addition, the availability of implants, devices, and a series of surgical instruments may be inadequate, especially with regard to remote or under-displayed surgical facilities. Cleaning, sterilization, and maintenance of surgical components can be time consuming and expensive, especially with a series of surgical instruments designed to be used repeatedly. In addition, cleaning and sterilization procedures can lead to significant latency or interruption times when involved in scheduling a number of successive surgical procedures.

  Therefore, there is a general need in the art to provide improved surgical kits and methods that provide sterilized instruments for use in spinal surgery. The present invention fulfills this need and provides other benefits and advantages in a novel and non-obvious manner.

  The present invention relates generally to surgical kits and methods for providing sterilized instruments for use in spinal surgery. While the actual nature of the invention addressed herein may only be determined with reference to the appended claims, the following is a description of certain forms of the invention that illustrate the features of the preferred embodiments disclosed herein. Briefly described.

  In one aspect of the invention, a spinal implant adapted to engage a portion of the spinal column, a series of instruments adapted to be used in conjunction with spinal surgery, the spinal implant and the series prior to spinal surgery. A surgical kit for use in spinal surgery is provided that includes a package adapted to contain the instrument in a sterile condition.

  In another aspect of the invention, providing a surgical instrument set including a spinal implant and a series of associated surgical instruments; packaging the surgical instrument set in a sealed container; and Disclosed is a method for providing a sterilized surgical instrument for use in spinal surgery that includes sterilizing and delivering the surgical instrument set to a surgical site.

  Other aspects of the invention will become apparent from the drawings and the following description.

  Here, for the purpose of promoting an understanding of the principle of the present invention, the embodiments shown in the drawings will be described with reference to specific terms. Nonetheless, it is not intended to limit the scope of the invention, but rather to the device changes and other modifications shown and described herein, as would normally occur to one skilled in the art to which the invention pertains. It will be appreciated that other applications of the principles of the present invention are contemplated.

  Referring to FIG. 1, a surgical kit 10 is shown for use in conjunction with spinal surgery, according to one embodiment of the present invention. The surgical kit 10 generally comprises a surgical instrument set 12 and a package 14 that houses and maintains the surgical instrument set 12 in a sterile condition prior to surgery. Surgical instrument set 12 may include spinal implants of various sizes and configurations and associated components and / or instruments suitable for use in spinal surgical procedures. In the illustrated embodiment, the surgical instrument set 12 is used in securing a spinal implant 20, several bone anchors 22 that secure the spinal implant 20 to a portion of the spinal column, and the spinal implant 20 to the spinal column. A series of surgical instruments 24 are included. However, the surgical instrument set 12 may include other types and configurations of spinal implants and related components and / or instruments suitable for use in spinal surgical procedures, as will be described below.

  In other embodiments of the present invention, the surgical instrument set 12 includes all implants, components, and / or instruments for performing a designated spinal surgical procedure. In this method, the surgical kit 10 is self-contained including all the specialized equipment necessary to perform a designated spinal surgical procedure. However, it is contemplated that common surgical instruments such as surgical scalpels, retractors, local anesthesia and related devices, and / or other types of general surgical components and instruments, etc. are also contemplated for inclusion in surgical kit 10. Should be understood.

  In one embodiment of the present invention, the spinal implant 20 is configured as an elongate member that is used to immobilize and / or stabilize a portion of the spinal column, as described in more detail below. In the illustrated embodiment of the invention, the spinal implant 20 is configured as a spinal plate. However, it should be understood that the spinal implant 20 can be in other configurations, such as a rod, cable, or any type of elongated element suitable for use in immobilizing and / or stabilizing a portion of the spinal column. is there. Also, other types of spinal implants are contemplated for use in conjunction with the present invention, such as interbody implants, or any other type of implant suitable for use in spinal surgery. It should also be understood. It should further be appreciated that a bone growth promoting substance or material can be included in the surgical kit 10 to facilitate fusion with the spinal implant and / or fusion between adjacent vertebrae. Such bone growth materials / materials include, but are not limited to, natural bone materials including bone fragments or bone marrow, demineralized bone matrix (DBM), mesenchymal stem cells, bone morphogenetic proteins ( BMP: bone morphogenic protein (LMP), LIM mineralization protein (LMP), or any other suitable bone growth promoter or material can be included.

  In the illustrated embodiment of the present invention, the bone anchor 22 is configured as a bone screw suitable for use in engaging the spinal plate 20 with a portion of the spinal column, as will be described in further detail below. In one embodiment, the bone screw 22 is configured as a self-cutting screw, whereby a cutting instrument for anchoring the bone screw 22 in the vertebra, such as a drilling, tapping and / or guiding instrument, etc. No more requests. However, it should be understood that other types and configurations of bone screws are also contemplated for use with the present invention. It should also be understood that the bone anchor 22 can be in other configurations, such as bolts, hooks, staples, or other types of devices suitable for securing the spinal implant 20 to a portion of the spinal column.

  In the illustrated embodiment of the present invention, a series of surgical instruments 24 engage other components or elements configured to drive and engage bone screws 22 with the vertebrae and / or associated with spinal plate 20. It includes a drive device that engages, drives or operates, as will be described in more detail below. However, for use in conjunction with the present invention, for example, a distractor, an insertion tool, a holder, a guide, a cutting tool such as a saw, a drill, a tap, a trephine, a curette, a chisel, It should be understood that other types and configurations of surgical instruments are also contemplated, including and / or other types and configurations of instruments suitable for use in conjunction with spinal surgery.

  Referring generally to FIGS. 1 and 2, in one embodiment of the present invention, the package 14 generally includes an interior container 30 and an exterior container 32. The internal container 30 serves to house the surgical instrument set 12 and maintain its sterility until the point when the surgical instrument set 12 is to be used, usually immediately before or during the surgical procedure. Similarly, the outer container 32 serves to house the inner container 30 and maintain its sterility until the surgical instrument set 12 is to be utilized. However, it should be understood that in other embodiments of the present invention, the packaging 14 need not necessarily include the outer packaging 32. Further, although not specifically shown in the figures, the surgical kit 10 may be placed in an outer enclosure, such as a box, carton, envelope, bag, or other, to aid in the delivery, storage, and / or identification of the surgical kit 10. Can be placed in any suitable type of container or enclosure.

  In one embodiment of the invention, the inner container 30 and the outer container 32 are generally configured as trays, and the inner tray 30 is sized and configured to receive various components of the surgical instrument set 12 therein. In addition, several compartments or blisters 34a, 34b, 34c, and 34d are defined, and the outer tray 32 is sized and configured to receive the inner tray 30 therein. In one embodiment, the interior tray 30 and the exterior tray 32 are formed of a material that can be directly viewed by the surgical instrument set 12 contained therein, such as a transparent material, a clear material, or a translucent material. In this way, the contents of the surgical instrument set 12 can be confirmed or verified without having to open the package 14 and without compromising the sterility of the surgical kit 10. In certain embodiments, the interior tray 30 and the exterior tray 32 are formed of a substantially transparent plastic material. However, other types of packaging materials suitable for maintaining the sterility of the surgical kit 10 for use in conjunction with the present invention are also contemplated.

  In other embodiments of the present invention, the interior tray 30 and the exterior tray 32 include outer peripheries 36 and 38, respectively, for packaging considerations that facilitate handling of the trays 30 and 32, respectively. As shown in FIG. 1, the peripheral edge 36 of the interior tray 30 is placed on a shoulder 40 defined around the inner periphery of the exterior tray 32 so that the inner tray 30 is securely seated in the outer tray 32. Nest. The peripheral edge 36 of the inner tray 30 also defines a recess or insertion portion 42 that is offset from the sidewall of the outer tray 32 so as to define an open region 44. As will be appreciated, the open area 44 allows the inner tray 30 to be easily removed from the outer tray 32 by conveniently grasping the peripheral edge 36 of the inner tray 30.

  In another embodiment of the present invention, as shown in FIG. 2, the inner tray 30 is removably attached to the peripheral edge 36 to maintain the sterility of the surgical instrument set 12 contained therein. A seal or cover 46 is included. The surgical instrument set 12 can be selectively utilized by removing or peeling the seal 46 from the inner tray 30. Similarly, the outer tray 32 includes a seal or cover 48 that is removably attached to the peripheral edge 38 to maintain the sterility of the inner tray 30. The seal 48 can be removed from or peeled from the outer tray 32 to selectively utilize the inner tray 30.

  In one embodiment of the present invention, the surgical kit 10 is sterilized as a complete unit after sealing the surgical instrument set 12 in the interior container 30 and sealing the interior container 30 in the exterior container 32. Sterilization of the surgical kit 10 may be accomplished by radiation techniques, such as by exposing the surgical kit 10 to gamma radiation. However, it should be understood that the surgical kit 10 may be sterilized by suitable external sterilization techniques. It should also be understood that the surgical instrument set 12 may be sterilized and then sealed in the interior container 30, and further, the interior container 30 may be sterilized and then sealed in the outer tray 30. is there.

  Referring now to FIG. 3, a template 50 according to one embodiment of the present invention is shown for use with the surgical kit 10. Template 50 includes a number of graphic images or illustrations 52 corresponding to various sized and configured spinal implants and devices to be used in conjunction with a designated spinal surgical procedure. In one embodiment, template 50 provides a side view of spines and bone anchors of various sizes and configurations corresponding to spines 20 and bone anchors 22 of selected sizes and configurations included in a particular surgical kit 10. Show. Specifically, the template 50 includes a number of images 52 of spinal plates having various lengths and plate configurations. In addition, image 52 shows a bone anchor adapted to pivot relative to the spinal plate within a certain angular orientation range having a particular length. In other embodiments, the bone anchors and / or spinal plates are capable of relative translation between them, or are capable of combined relative pivoting and translation between them. May be adapted. It should also be understood that the bone anchor may be adapted to be placed in a predetermined fixed position and / or orientation relative to the spinal plate.

  In the illustrated embodiment of the invention, the surgical kit 10 includes a spinal plate 20 having a series of plate sizes, ie, a size selected from 23 mm, 25 mm, 27.5 mm, 40 mm, 42.5 mm, and 45 mm. These specific plate sizes were selected to meet a wide range of spinal surgical procedures and applications. For example, in the illustrated embodiment, the specified plate size was selected to meet the requirements of approximately 80% of spinal surgical procedures and applications utilizing a specific configuration of spinal plate 20. Further, in the illustrated embodiment of the present invention, the surgical kit 10 is provided with a variable angle bone screw 22 having a length of about 13 mm. This particular size and configuration of bone screws was selected for use in conjunction with a spine plate 20 of a specified size and configuration and to meet a wide range of spinal surgical procedures and application requirements. Although specific sized and configured spinal plates 20 and bone anchors 22 have been illustrated and described herein, the specified sizes and configurations of spinal plates and bone anchors are exemplary and never It should be understood that the scope of the present invention is not limited. Also, the components included in the surgical kit 10 maximize the use of the spinal kit 10 in conjunction with a wide range of spinal surgical procedures and applications, and perform such surgical procedures and applications. It should be understood that it is selected to minimize the overall inventory level of surgical instruments required.

  As will be appreciated, each image 52 illustrated on the template 50 corresponds to a specific size and configuration of related components such as the spinal implant 20 and bone anchor 22 included in a particular surgical kit 10. Thus, using the template 50, the surgical kit 10 including the spine plate 20 and bone screw 22 of the appropriate size and configuration necessary to meet the specific requirements of the spinal surgical procedure being performed, It can assist the surgeon or other health care professional in choosing. Specifically, the template image 52 is compared to the surface development of the treated portion of the spinal column so that the size and configuration of the spinal plate 20 and / or bone anchor 22 included in the surgical kit 10 are designated spines. It can be determined whether certain requirements of surgical procedures are met.

  In one embodiment of the invention, the front development against which the template image 52 is compared is an x-ray image. However, the template image 52 is compared against it using other suitable devices and techniques, such as magnetic resonance imaging (MRI), ultrasound imaging, or other types of imaging techniques. It should be understood that a visual surface development can be provided. As will be appreciated, x-ray surface development can sometimes be scaled up or down at a rate greater than or less than 100%. Therefore, it is preferable that the template 50 is marked so as to indicate an enlargement ratio (for example, 95%, 100%, 115%, etc.) due to the template image 52. As a result, the surgeon or other health care professional matches the magnification rate associated with the template 50 with the magnification rate associated with the x-ray table development so that the spinal implant 20 and / or bone of the appropriate size and / or configuration is obtained. An appropriate selection of the anchor 22 can be ensured. The surgical kit 10 may be provided with a single template 50 to accommodate X-ray surface development with a selected magnification, or it corresponds to X-ray surface development with a range of magnifications. It should be understood that multiple templates 50 may be provided. In other embodiments of the present invention, a conversion table may be included in the surgical kit 10 to help calculate an appropriate conversion rate related to the magnification factor resulting from the template 50 and / or X-ray table development. Good.

  In other embodiments of the present invention, the template 50 is attached to the exterior of the outer container 32 or to the exterior of an outer box or enclosure (not shown) in which the surgical kit 10 is housed. As a result, the template 50 is made available to the surgeon or other medical personnel without having to open the package 14. Thus, if the particular size and / or configuration of spinal implant 20 and / or bone anchor 22 included in the surgical kit 10 does not meet the specific requirements of a designated spinal surgical procedure, the interior container 30 and / or Alternatively, the sterility of the surgical instrument 12 contained therein is not impaired. In one embodiment, the template 50 is contained in a plastic bag or envelope (not shown), which is then attached to the exterior of the outer container 32 or the exterior box or enclosure. However, it should be understood that other suitable devices and techniques may be used to attach the template 50 to the surgical kit 10 or otherwise include the template 50 in the surgical kit 10.

  Referring to FIG. 4, an exploded view of the drive device 24 is shown. The drive device 24 extends generally along the longitudinal axis L and includes a shaft portion 26 and a handle portion 28. In one embodiment of the invention, shaft 26 and handle 28 are configured as separate parts that are assembled or otherwise integrated to form drive device 24. Since the shaft 26 and the handle 28 are configured as separate parts, the overall size (eg, length) of the package 14 can be reduced. Furthermore, when the drive device 24 is in a two-part configuration, the distal portion of the shaft 26 can be inverted with respect to the handle 28 so that the drive device 24 can be equipped with an alternative end configuration. Details will be described later. However, it should be understood that in other embodiments of the present invention, the shaft 26 and handle 28 can be integrally formed with each other to form a single piece drive 24.

  In one embodiment of the invention, the shaft 26 includes a central portion 60 and first and second end portions 62 and 64 at both ends. In certain embodiments, the central portion 60 is a hexagonal configuration, although other suitable shapes and configurations are also contemplated. In other embodiments, the first and second end portions 62 and 64 are shaped in a configuration suitable for engaging various elements and components associated with the spinal plate 20 and / or the bone anchor 22. The details will be described later. In this manner, the drive instrument 24 allows the shaft 26 to engage, drive, move and / or manipulate one or more elements or components associated with the spinal plate 20 and / or the bone anchor 22. It is multifunctional in that it is possible.

  In the illustrated embodiment of the drive instrument 24, the first end portion 62 of the shaft 26 defines a drive tip 66 sized and configured to be inserted into the tool receiving recess defined by the bone screw 22. To do. In certain embodiments, the drive tip 66 is a hexagonal configuration. However, it should be understood that other suitable shapes and configurations of the drive tip 66 are contemplated for use with the drive device 24. Second end portion 64 of shaft 26 defines a drive tip 68 sized and configured to be inserted into a tool receiving recess defined by another element or component associated with spinal plate 20. The details will be described later. In certain embodiments, the drive tip 68 is a cruciform or Philips configuration. However, it should be understood that other suitable shapes and configurations of the drive tip 68 are contemplated for use with the drive device 24.

  In one embodiment of the present invention, the handle 28 of the drive device 24 includes a body portion 70 and a distal end portion 72 that is rotatably coupled to the body portion 70 to provide a longitudinal axis L. Allows relative rotation between them around. This particular configuration of the handle 28 improves the ease of use associated with driving rotation of the drive device 24 with one hand. More specifically, the distal end portion 72 can be gripped in the user's palm or between the user's pinky finger and the palm while the body portion 70 is rotated between the user's thumb and index finger. Then, the shaft 26 rotates correspondingly. However, it should be understood that other configurations of handle 28 are contemplated for use in conjunction with drive device 24, including a single piece handle configuration.

  The body portion 70 of the handle 28 defines an axial opening 74 sized and configured to receive a portion of the shaft 26 therein. In one embodiment, the axial opening 74 has a shape that corresponds to the outer shape of the shaft 26. In certain embodiments, the axial opening 74 is a hexagon sized to receive the hexagonal central portion 60 of the shaft 26 therein. In this manner, the shaft 26 is engaged with the handle 28 so as to substantially prevent relative rotation with the handle 28. However, it should be understood that other suitable shapes and configurations of the axial opening 74 and the central shaft portion 60 are also contemplated, such as a rectangular, polygonal, circular, or elliptical configuration. It should also be understood that other means to prevent relative rotation between the shaft 26 and handle 28 are also contemplated, such as by pinning or fastening engagement.

  In other embodiments of the drive device 24, the handle 28 includes a retention mechanism 76 that is configured to selectively maintain axial engagement between the shaft 26 and the handle 28. In certain embodiments, the retention mechanism 76 includes a ring or band 77 disposed around the handle 28 and a detent device 78 supported by the ring 77 and in communication with the axial opening 74. Including. In other particular embodiments, the detent device 78 serves to cause the central shaft portion 60 to be slidably inserted into and selectively removed from the axial opening 74. Includes bearings. The detent device 78 also serves to assist in selectively maintaining the shaft 26 in axial engagement with the handle 28 by exerting a lateral force on the central shaft portion 60. However, it should be understood that other means of maintaining axial engagement between the shaft 26 and handle 28 are also contemplated, such as by pinning, fastening, or threaded engagement.

  In other embodiments of the present invention, the series of instruments 24 included in the surgical kit 10 are designed to be systematically disposable when used in conjunction with a limited number of spinal surgeries. In certain embodiments, the series of instruments 24 is designed to be used only once in conjunction with a single spine surgery. However, it should be understood that in other embodiments, the series of instruments 24 may be designed for multiple spinal surgeries, including two, three, or more than four spine surgeries. . In other words, the series of instruments 24 may be designed to have a predetermined period of use that is used in conjunction with a limited number of spinal surgeries, after which the series of instruments 24 is disposed of. If the series of instruments 24 included in the surgical kit 10 are designed for a single use, they are disposed of immediately and are associated with cleaning, sterilizing, repackaging, and / or storing the series of instruments for repeated use. Eliminate requirements and costs.

  In one embodiment of the present invention, at least a portion of a series of instruments will degrade when exposed to a sterilization procedure, such as an autoclave or other sterilization technique. In one embodiment, at least a portion of the series of instruments 24 deforms when exposed to a sterilization procedure. In other embodiments, at least a portion of the series of instruments 24 will change color when exposed to a sterilization procedure. However, other types of degradation, such as bending, reduced strength, cracking, fracture, pitting, flaking, decomposition, dissolution, or any other form of degradation are within the scope of the invention. Intended to enter. Degradation of at least a portion of the series of instruments 24 can occur gradually through exposure to multiple sterilization procedures, or it can occur immediately after exposure to a single sterilization procedure, which will also be described below. .

  In one embodiment of the present invention, the shaft 26 of the drive instrument 24 is formed of a metallic material, such as steel or other material suitable for surgical applications, and the shaft 26 has undergone a sterilization procedure, such as autoclave sterilization. Coated with materials that tend to discolor or foul in some cases. In certain embodiments, the shaft 26 is coated with a hard chrome material that tends to discolor or foul when exposed to sterilization treatment to form a stain or spot. However, other suitable materials or material coatings are also contemplated for use with shaft 26. It will be appreciated that discoloration or fouling of the shaft 26 will inhibit or deter further use of the shaft 26 and thus limit the use of a series of instruments 24 to only one surgical procedure. Should.

  In other embodiments of the invention, the handle 28 is formed of a plastic or polymer material, such as a polycarbonate material, which has a tendency to deform when the handle 28 is subjected to a sterilization procedure, such as autoclaving. In one embodiment, the axial opening 74 and / or retention mechanism 76 of the handle 28 deforms, degrades, or otherwise changes when exposed to a sterilization procedure so that the shaft 26 is axially open. 74 is inserted or prevents the shaft 26 from being removed from the axial opening 74. Deformation of the handle 28 will inhibit or deter further use and thus limit the use of the series of instruments 24 to a limited number of surgical procedures.

  In a particular embodiment of the present invention, the shaft 26 is designed to discolor or foul after a single sterilization attempt and the handle 28 is designed to deform so that a series of The use of instrument 24 will be limited to a single surgical procedure. However, in other embodiments, the shaft 26 may be designed to gradually discolor or foul after being subjected to multiple sterilization procedures and / or the handle 28 is designed to gradually deform. Alternatively, it allows multiple uses of a series of instruments 24 in a controlled number of times.

  Referring to FIGS. 5 and 6, the spinal plate 20 is shown anchored by the bone screw 22 to the neck of the spinal column, more specifically to the front of the upper cervical vertebra 80 and the lower cervical vertebra 82. However, it should be understood that the surgical kit 10 may be used in conjunction with other regions of the spine, such as the thoracic vertebrae, lumbar vertebrae, lumbosacral vertebrae, sacral vertebrae, and / or the back of the spine. It should also be understood that the spinal plate 20 may be applied to other aspects of the vertebrae by other surgical approaches, such as anterolateral, oblique, and posterior surgical approaches. In the illustrated embodiment of the invention, spinal plate 20 is sized and configured to span three vertebral levels. However, it will be appreciated that the spinal plate 20 may be sized and configured to extend over any number of vertebral levels, including a single vertebral level, two vertebral levels, or four or more vertebral levels. Should.

  In the illustrated embodiment of the invention, the interbody implant 84 extends between the upper cervical vertebra 80 and the lower cervical vertebra 82 to provide stability and / or support to the treated portion of the spinal column. Alternatively, it is positioned in the opening 86. However, it should be understood that the interbody implant 84 need not be used in conjunction with the spinal plate 20 to provide stability and support to the spinal column. In the illustrated embodiment, the interbody implant 84 is configured as a bone graft. However, other types and configurations of interbody implants and related devices for use with spinal plate 20, such as bone dowels, struts, spacers, push-in cages, screw-in cages, tapered cages, etc. Also contemplated are mesh cages, cages filled with bone grafts and / or graft substitutes, articulated implants, or other types of suitable interbody implants. The spinal plate 20 and / or interbody implant 84 may be used in conjunction with a fusion type application that facilitates interbody fusion between adjacent vertebrae, and a spacer type application that generally serves to maintain spacing between adjacent vertebrae without fusion. It should be understood that it may be used in conjunction and / or in conjunction with articulated applications that serve to significantly restore normal biomechanical motion to the treated portion of the spinal column.

  Although the illustrated embodiment of the surgical kit 10 does not include an interbody implant 84, it should be understood that in other embodiments of the invention, the surgical kit 10 may include an interbody implant 84. is there. Also, the interbody implant 84 is a device used in conjunction with the formation of the intervertebral space 86, preparation of the interbody implant 84 for implantation, and / or insertion of the interbody implant 84 into the intervertebral space 86. It should also be understood that it may be incorporated into a separate surgical kit including and / or instruments. Such an interbody implant kit or surgical kit 10 may also include an amount of a bone growth promoting substance or material to facilitate fusion with the interbody implant and / or between adjacent vertebrae. it can. Such bone growth materials / materials include, but are not limited to, natural bone material including bone fragments or bone marrow, demineralized bone matrix (DBM), mesenchymal stem cells, bone morphogenetic protein (BMP), LIM mineralized protein (LMP), or any other suitable bone growth promoting substance or material can be included.

  As shown in FIG. 5, the spinal plate 20 includes a number of bone anchor openings 90 that are each sized and configured to receive one bone anchor 22. Each bone anchor opening 90 includes a spherical recessed portion 92, the purpose of which will be described later. In the illustrated embodiment, the spinal plate 20 is a pair of bone anchors disposed adjacent to both ends of the spinal plate 20 to ensure anchoring of the spinal plate 20 to the upper vertebra 80 and the lower vertebra 82. An opening 90 is included. Also, a number of bone anchor openings 90 are provided to optionally anchor the spinal plate 20 to the interbody implant 84 and / or to an intermediate vertebra placed between the upper vertebra 80 and the lower vertebra 82. May be disposed along the central portion of the spinal plate 20. Bone anchor openings 90 disposed along the central portion of spinal plate 20 may also serve to allow direct viewing of a portion of interbody implant 84 and / or intermediate vertebrae. Further details regarding spinal plate 20 and other devices and components associated therewith are shown and described in US Pat. No. 6,152,927 to Faris et al., The contents of which are incorporated herein by reference. To do.

  The spinal plate 20 is fixed to the upper vertebra 80 and the lower vertebra 82 by a plurality of bone screws 22. In the illustrated embodiment of the invention, four bone screws 22 are used to engage spinal plate 20 with upper vertebra 80 and lower vertebra 82. However, it should be understood that any number of bone screws 22 may be used, including two, three, five or more bone screws 22. The bone screw 22 generally includes a screw shaft portion 100 sized to pass through each bone anchor opening 90 of the spinal plate 20 and a head portion 102 configured to abut the spinal plate 20. Although specific types and configurations of bone screws have been illustrated and described herein, it should be understood that other types and configurations of bone screws are also contemplated for use in conjunction with the present invention.

  In one embodiment of the present invention, the threaded shaft portion 100 of the bone screw 22 defines a male thread 104 adapted to engage bone, more specifically cortical bone and / or cancellous bone of the vertebra. . As previously described, the bone screw 22 may be configured as a self-cutting screw, thereby providing additional instruments, such as drilling, tapping, and / or for securing the spinal plate 20 to the vertebrae 80,82. It is possible to eliminate the requirement for guidance equipment. In certain embodiments, the screw shaft 100 includes a grooved or recessed region 106 that extends across several threads 104 to facilitate self-drilling and / or self-tapping into the bone. In other embodiments, the distal end portion 108 of the screw shaft 100 may be tapered and / or sharpened to facilitate penetration into the bone.

  In other embodiments of the present invention, the head portion 102 of the bone screw 22 includes a spherical surface 110 that is substantially complementary to a spherical recess portion 92 defined by the bone anchor opening 90. By engaging the spherical surface 110 of the screw head 102 with the spherical recess portion 92 of the opening 90, the bone screw 22 can be pivoted within an angular orientation range α (FIG. 6) relative to the spinal plate 20. Can be positioned. This variable angle feature allows the surgeon to engage the bone screw 22 with the upper vertebra 80 and the lower vertebra 82 within a range of angular orientations, thereby placing the spinal plate 20 on the particular portion of the spinal column being treated. When fixed, a higher degree of freedom is provided. In addition, this variable angle function allows a limited degree of fine or translational movement between the bone screw 22 and the spinal plate 20, which can prevent or at least reduce an increase in load stress. .

  In other embodiments of the present invention, the head portion 102 of the bone screw 22 is configured to receive a distal portion of the drive device 24 therein to facilitate driving the bone screw 22 into the bone. A tool receiving recess 112 (FIG. 5) is defined. In one particular embodiment, the tool receiving recess 112 is a hexagonal configuration sized and configured to receive the hexagonal tip 66 of the drive device 24 in an engaging manner therein. However, it should be understood that other suitable shapes and configurations of the tool receiving recess 112 are also contemplated for use in conjunction with the bone anchor 22.

  As shown in FIG. 5, the spinal plate 20 includes a number of retention devices 120 configured to engage the bone screws 22 to prevent the bone screws 22 from loosening and disengaging from the vertebrae. In one embodiment, the retention device 120 is configured as a threaded fastener 122 and a washer 124. Fastener 122 abuts against washer 124 and a screw shaft configured to threadably engage within a screw hole (not shown) defined by spinal plate 20 to cause washer 124 to be bone screw 22. A head portion configured to be pressed into engagement with the head portion 102 of the head. To facilitate driving the fastener 122 into a screw hole (not shown) in the spinal plate 20, the head portion of the fastener 122 is configured to receive the distal portion of the drive device 24 therein. A defined tool receiving recess 126 is defined. In one embodiment, the tool receiving recess 126 is a cruciform or philips type configuration sized and configured to engagably receive the cruciform tip 68 of the drive device 24 therein. However, it should be understood that other suitable shapes and configurations of tool receiving recesses 126 are also contemplated for use in conjunction with fasteners 122.

  Having described the basic features and components of the spinal plate 20 and bone anchor 22, reference will now be made to techniques for engaging the spinal plate 20 to the spinal column, according to one embodiment of the present invention. Initially, an x-ray of the treated portion of the patient's spinal column is taken to provide visual development of the spinal anatomy. The template 50 then provides an x-ray representation of the patient's spinal column to determine the appropriate size and / or configuration of the spinal plate 20 and / or bone anchor 22 to be used in conjunction with the designated spinal surgical procedure. Overlaid on the statue. The template 50 is attached to the exterior of the outer container 32 or to the exterior of the outer box or enclosure (not shown) in which the surgical kit 10 is housed so that the surgeon or other medical personnel without opening the package 14 Can use the template 50. As a result, the sterility of the interior container 30 and the surgical instrument set 12 is maintained.

  Once the correct sized and / or configured spine plate 20 and / or bone anchor 22 to be used in conjunction with the designated surgical procedure is identified, the seal 48 (FIG. 2) on the outer container 32 is removed to provide an inner container. 30 can be made available. Because the inner container 30 is maintained in a sterile state, it can be brought directly into a sterile operating room environment. After removing the inner container 30 from the outer container 32, the seal 46 on the inner container 30 can be removed to utilize the surgical instrument set 12, more specifically the spinal plate 20, the bone anchor 22, and the drive instrument 24. Can be. Inserting the distal portion 64 of the drive shaft 26 into the axial opening 74 of the handle 28, the drive instrument 24 is first assembled and the drive instrument 24 is equipped with a hexagonal drive tip 66. As described above, the holding mechanism 76 serves to maintain the axial engagement between the shaft 26 and the handle 28.

  The treated portion of the spinal column is accessed by an anterior approach and when an interbody implant 84 is used in conjunction with a surgical procedure, an intervertebral opening or intervertebral space between the upper vertebra 80 and the lower vertebra 82 is used. 86 is formed. The interbody implant 84 is inserted into the intervertebral opening 86 and the spinal plate 20 is positioned along the anterior surface of the spinal column to extend between the upper vertebra 80 and the lower vertebra 82. The spinal plate 20 can then be secured to the upper vertebra 80 and the lower vertebra 82 by engaging the bone anchor 22 with the vertebra. Specifically, the hexagonal drive tip 66 of the drive device 24 is inserted into a correspondingly shaped tool receiving recess 112 formed in the head 102 of the bone screw 22. The screw shaft 100 of the bone screw 22 is inserted into each bone anchor opening 90 in the spinal plate 20 with an appropriate angular orientation α relative to the spinal plate 20. The self-cutting shaft 100 is then driven into the vertebra until the spherical surface 110 of one screw head 102 is intimately engaged with the spherical recess portion 92 of the bone anchor opening 90.

  After engaging spinal plate 20 with upper vertebra 80 and lower vertebra 82, shaft 26 of drive device 24 is removed from axial opening 74 in handle 28 and distal portion 62 is inserted into axial opening 74. Then, it is assembled with the handle 28 again, and the drive device 24 is equipped with a cross-shaped drive tip 68. Also in this case, the holding mechanism 76 serves to maintain the axial engagement between the shaft 26 and the handle 28. The retaining device 120 is then engaged against the screw head 102 to prevent the bone screw 22 from loosening and coming off. Specifically, the cruciform drive tip 68 of the drive device 24 is inserted into the correspondingly shaped tool receiving recess 126 in the fastener 122 and the fastener 122 is spine until the washer 124 contacts the screw head 102. The screw 20 is advanced into a screw hole (not shown) in the plate 20. As the fastener 122 is threadedly advanced within the spinal plate 20, engagement of the fastener 122 with the vertebrae is provided, thereby further securing the spinal plate 20 to the upper vertebra 80 and the lower vertebra 82.

  While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character and is within the spirit of the invention. Protection of all changes and modifications is desired.

1 is a perspective view of a surgical kit used in spinal surgery, according to one embodiment of the present invention, with the kit wrap seal removed for clarity of illustration. FIG. FIG. 2 is an exploded view of a package associated with the surgical kit shown in FIG. 1. 2 is a surgical template according to an embodiment of the present invention used in conjunction with the surgical kit shown in FIG. FIG. 2 is an exploded view of a surgical instrument according to an embodiment of the present invention used in conjunction with the surgical kit shown in FIG. FIG. 2 shows a spinal fixation plate according to one embodiment of the present invention used in conjunction with the surgical kit shown in FIG. 1 when anchored to the anterior neck of the spinal column. FIG. 6 is a lateral side view of the embodiment of the present invention shown in FIG. 5.

Claims (55)

A spinal implant;
A series of instruments adapted for use in conjunction with spinal surgery;
A surgical kit for use in spinal surgery comprising the spine implant and a package adapted to house and maintain the series of instruments in a sterile condition prior to the spinal surgery.   The surgical kit of claim 1, wherein the spinal implant is adapted to engage between a first vertebra and a second vertebra.   The surgical kit of claim 2, wherein the spinal implant includes an elongate member and a number of bone anchors adapted to secure the elongate member to the first and second vertebrae.   The surgical kit according to claim 3, wherein the elongate member includes a spinal plate and the bone anchor includes a bone screw.   The surgical kit of claim 1, wherein the spinal implant includes an interbody implant adapted to be placed in an intervertebral space between a first vertebra and a second vertebra.   The surgical kit according to claim 5, further comprising a bone growth promoting substance disposed between the first vertebra and the second vertebra to promote fusion.   The surgical kit of claim 1, wherein the series of instruments is designed to be disposed of in a planned manner.   The surgical kit of claim 1, wherein the series of instruments is designed to be used in conjunction with a limited number of spinal surgeries.   The surgical kit of claim 8, wherein the series of instruments is designed to be used in conjunction with a single spine surgery.   The surgical kit of claim 1, wherein at least a portion of the series of instruments undergoes degradation when exposed to a sterilization procedure.   The surgical kit according to claim 10, wherein the deterioration comprises a deformation.   The surgical kit according to claim 10, wherein the degradation includes a discoloration.   The surgical kit of claim 10, wherein the degradation occurs gradually upon exposure to multiple sterilization procedures.   The surgical kit according to claim 10, wherein the degradation occurs immediately after exposure to a single sterilization procedure.   The surgical kit according to claim 10, wherein the sterilization procedure includes autoclave sterilization.   The surgical kit of claim 10, wherein the deterioration renders the series of instruments substantially inoperable.   The surgical kit according to claim 1, wherein the series of instruments includes a first portion and a second portion, the first portion being selectively engageable with the second portion.   The first portion of the series of instruments includes a shaft, the second portion of the series of instruments includes a handle, and the shaft includes first and second end portions at opposite ends. The first and second end portions are invertible with respect to the handle; the first end portions are adapted to perform a first function associated with spinal surgery; and the second end portions The surgical kit of claim 17, wherein the portion is adapted to perform a second function associated with spinal surgery.   The first end portion includes a first tip configuration adapted to engage a first element associated with the spinal implant, and the second end portion includes a first tip associated with the spinal implant. The surgical kit of claim 18, comprising a second tip configuration adapted to engage the two elements.   The surgical kit of claim 1, wherein the series of instruments is configured to perform a number of functions associated with spinal surgery.   The surgical kit of claim 1, wherein the package is adapted to house the spinal implant and the series of instruments together.   The surgical kit of claim 21, wherein the package includes a plurality of compartments sized to receive therein the spinal implant and each component of the series of instruments.   The surgical kit of claim 1, wherein the package is formed of a material that allows direct viewing of the spinal implant and the series of instruments contained therein.   The package includes an inner container and an outer container, the inner container being adapted to receive and maintain the spinal implant and the series of instruments in the sterile state, the outer container being the spine surgery. The surgical kit of claim 1, wherein the surgical kit is adapted to previously contain and maintain the inner container in a sterile condition.   The outer container includes a removable first seal to selectively utilize the inner container, the inner container selecting the spinal implant and the series of instruments contained therein 25. The surgical kit of claim 24, comprising a removable second seal for making available for use.   Further comprising a template including a number of images corresponding to one or more selected sizes of the spinal implant, wherein one of the template images corresponds to the size of the spinal implant included in the surgical kit. The surgical kit according to claim 1.   27. The surgical kit of claim 26, wherein the template is provided on the exterior of the package to allow the template to be utilized without compromising the sterility of the spinal implant and the set of instruments.   27. The surgical kit of claim 26, wherein the template includes an indication of a magnification factor associated with the template image.   The surgical kit of claim 1, wherein the surgical kit is self-contained including all surgical instruments necessary to perform a designated spinal surgery. A spine plate, a number of bone screws adapted to secure the spine plate to the first and second vertebrae, and a drive instrument adapted to drive the bone screws into engagement with the vertebrae A surgical instrument set, and packaging adapted to contain and maintain the surgical instrument set in a sterile condition prior to spinal surgery;
A surgical kit for use in spinal surgery.   The surgical kit according to claim 30, wherein the bone screw is a self-cutting bone screw.   31. The surgical kit of claim 30, wherein the bone screw is a variable angle screw.   31. The surgical kit of claim 30, wherein the surgical instrument set includes an interbody implant adapted to be placed in an intervertebral space between the first vertebra and the second vertebra.   31. A surgical kit according to claim 30, wherein the drive instrument is designed for planned disposal.   32. The surgical kit of claim 30, wherein at least a portion of the drive instrument undergoes degradation when exposed to a sterilization procedure.   The drive device extends generally along a longitudinal axis and includes a shaft portion and a handle portion, the handle portion includes a first portion, and the first portion is rotatably coupled to the second portion. 31. The surgical kit of claim 30, wherein the surgical kit provides relative rotational motion between them about a longitudinal axis.   31. The surgical kit of claim 30, wherein the drive instrument includes a shaft portion and a handle portion, the shaft portion being selectively engageable with the handle portion.   The shaft portion includes first and second end portions at opposite ends, the first and second end portions are invertible with respect to the handle portion, and the first end portion is in the bone screw A first tip configuration adapted to engage, wherein the second end portion includes a second tip configuration adapted to engage a second element associated with the spinal plate. The surgical kit according to claim 37.   Further comprising a template including a number of images corresponding to one or more selected sizes of the spinal plate, wherein one of the template images corresponds to the size of the spinal plate included in the surgical kit. 31. The surgical kit of claim 30, wherein the template is provided external to the package so that the template can be utilized without compromising the sterility of the spinal plate and the set of instruments. A method for providing a sterile surgical instrument for use in spinal surgery comprising:
Providing a surgical instrument set including a spinal implant and a series of instruments adapted to be used in conjunction with spinal surgery;
Packaging the surgical instrument set in a sealed container;
Sterilizing the surgical instrument set;
Delivering a set of surgical instruments to a site for performing spinal surgery, and providing a sterilized surgical instrument for use in spinal surgery.   41. The method of claim 40, wherein the spinal surgery includes engaging the spinal implant between a first vertebra and a second vertebra.   42. The method of claim 41, wherein the spinal implant includes an elongate member and the engaging step includes securing the elongate member to the first and second vertebrae with a plurality of bone anchors.   The spinal implant includes an interbody implant, and the engaging step includes inserting the interbody implant into an intervertebral space between a first vertebra and a second vertebra. 42. The method of claim 41.   42. The method of claim 41, wherein the surgical instrument set includes a bone growth promoting material disposed between the first vertebra and the second vertebra to facilitate fusion.   Further comprising providing a template including a number of images corresponding to one or more selected sizes of the spinal implant, wherein one of the template images is included in the surgical instrument set. 41. The method of claim 40, corresponding to the size of the implant. Comparing the template image with visual surface development of a portion of the spinal column undergoing spinal surgery;
46. The method of claim 45, further comprising selecting a surgical instrument set that includes a spinal implant of a size suitable for use in conjunction with spinal surgery. Providing the template with a display corresponding to a magnification factor associated with the template image;
47. The method of claim 46, further comprising: selecting a magnification factor associated with the visual surface development that corresponds to the magnification factor associated with the template image.   46. The method of claim 45, wherein the template is provided external to the sealed container and the method further comprises utilizing the template without compromising the sterility of the surgical instrument set.   41. The method of claim 40, further comprising disposing of the series of instruments after a selected number of spine surgeries.   52. The method of claim 49, wherein the disposing step occurs after completion of only one spinal surgery.   The series of instruments includes separate first and second parts, and the method further comprises assembling the first part and the second part after the delivering step. 41. The method according to 40. The first portion of the series of instruments includes a handle, and the second portion of the series of instruments includes a shaft including first and second end portions at opposite ends; But,
Performing a first function by the first end portion of the shaft;
Reversing the position of the first and second end portions of the shaft relative to the handle;
52. The method of claim 51, further comprising performing a second function with the second end portion of the shaft. The sealed container includes an inner sealed container and an outer sealed container;
41. The method of claim 40, wherein the step of packaging includes packaging the surgical instrument set in the inner sealed container and packaging the inner sealed container in the outer sealed container.   The providing step includes selecting a spinal implant having a specific size from a selected size range, the selected size range being based on predicted spinal implant usage criteria. 41. The method of claim 40.   41. The method of claim 40, further comprising providing all surgical components necessary to perform a designated spinal surgery to the surgical instrument set.

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